NEEM HAND SANITIZER- hand sanitizer spray
Maharishi Ayur-Ved Products International Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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NEEM HAND SANITIZER

Active Ingredient Ethyl Alcohol 62% v/v.

Purpose Antiseptic

Uses: Hand sanitizer to help reduce germs that potentially can cause disease. Recommended for repeated use.

Warnings For external use only. Flammable. Keep away from fire or flame.

Do not use in children less than 2 months of age. On open skin wounds.

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious problem.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions Spray enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 to avoid swallowing.

Other information Store between 15-30C (59-86F). Avoid freezing and excessive heat above 40C (104F).

Inactive Ingredients: Aqua (purified water), Organic glycerin (vegetable), Aloe barbadensis (aloe vera) leaf juice, Herb blend [Curcuma zedoaria (white turmeric) rhizome extract, Azadirachta indica (neem) leaf extract], Menthol, Mentha piperita (peppermint) oil.

NEEM HAND SANITIZER

2oz label NDC 81587-622-02

NEEM HAND SANITIZER
hand sanitizer spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81587-622
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MENTHOL (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
CURCUMA ZEDOARIA ROOT (UNII: 123C43G128)
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:81587-622-02	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/01/2021

Labeler - Maharishi Ayur-Ved Products International Corporation (024177843)

Registrant - Maharishi Ayur-Ved Products International Corporation (024177843)

Name	Address	ID/FEI	Business Operations
Establishment
Royal Labs Natural Cosmetics, Inc.		197478480	manufacture(81587-622)

Revised: 8/2021

Document Id: c3cf3c8b-44fe-899e-e053-2995a90aa60e

Set id: c3cf3c8b-44fe-899e-e053-2995a90aa60e

Version: 1

Effective Time: 20210801

Maharishi Ayur-Ved Products International Corporation